MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD EAGLE INFLATION DEVICE

Model Number	325110
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the inflation device pump to inflate the balloon did not work.
Event or Problem Description
It was reported that the inflation device pump to inflate the balloon did not work.
Additional Manufacturer Narrative
The reported event was confirmed as use-related.An evaluation was completed by (b)(6) on 27jan2021.A visual inspection was performed upon receipt of the complaint device.It was noted that the gauge needle was not in the zero box.The right clamp on the device was cracked and broken.The pivot pin/locking mechanism area of the housing also exhibited impact marks.No other anomalies were reported during visual inspection.After the visual inspection was performed, functional testing was performed.The device was connected to a pressure indicator and an attempt was made to fill the device with distilled water and aspirate it.The device could not draw in water because the right clamp was broken and the o-ring was out of position.The broken clamp and dislocated o-ring were removed and replaced with new parts.The device was connected to a pressure indicator, aspirated, and functionally tested.The latch was engaged, and the plunger was rotated clockwise to pressurize the device.The gauge accuracy test was performed on the device, and it failed at the 4atm, 14atm, and 30atm areas, due to the gauge needle being off zero upon receipt.The device passed the pressure leak test, the pressure decay test, and the vacuum capability tests.A broken clamp, displaced o-ring, and gauge needle outside of the zero position, occurs when a device is over-pressurized beyond the pressure capability, in this case 30 atm.Since the device passed full functional testing prior to shipment and a new clamp and o-ring were placed onto the device, the root-cause was determined to be over-pressurization by the user.The device history record review was not required as the reported event was confirmed as use-related.The instructions for use were found adequate and state the following: "do not exceed 30 atm".H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: BARD EAGLE INFLATION DEVICE
• Common Device Name: BARD EAGLE INFLATION DEVICE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10623201
• Report Number: 1018233-2020-06322
• Device Sequence Number: 2880830
• Product Code: KOE
• UDI-Device Identifier: 00801741067242
• UDI-Public: (01)00801741067242
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K962611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 325110
• Device Catalogue Number: 325110
• Device Lot Number: BMCPAT01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1